NCT04758624 · Northwell Health
Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract
What this study is about
The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation
View original scientific description
The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation
Interventions
DEVICE
Deep Brain Stimulation
Medtronic Activa device will be implanted and administered clinically, except as part of the trial after 24 months of DBS being on it will be turned off for 3 days and will be turned back on.
Primary outcome measures
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
Time frame: Baseline before DBS implant
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
Time frame: 24 months after start of DBS
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time frame: Baseline before DBS implant
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time frame: 24 months after start of DBS
Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time frame: Baseline before DBS implant
Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time frame: 24 months after start of DBS
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time frame: Baseline before DBS implant
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time frame: 24 months after start of DBS
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Time frame: Baseline before DBS implant
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Time frame: 24 months after start of DBS
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Time frame: Baseline before DBS is turned off
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Time frame: 72 hours after DBS is turned off
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Time frame: Baseline before DBS implant
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Time frame: 24 months after start of DBS
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Time frame: Baseline before DBS is turned off
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Time frame: 72 hours after DBS is turned off
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Time frame: During DBS placement surgery before active DBS
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Time frame: During DBS placement surgery during active DBS
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Spectral power recorded during intraoperative electrocorticography (ECoG)
Time frame: During DBS placement surgery before active DBS
Spectral power recorded during intraoperative electrocorticography (ECoG)
Time frame: During DBS placement surgery during active DBS
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- the diagnosis of Essential Tremor, made by a movement disorder neurologist, where tremor is not secondary to any disease process or traumatic insult
- distal appendicular tremor, with minimal proximal component
- tremor refractory to multiple medication regimens and/or where the medications cause intolerable side effects
- tremor judged to be severely impacting their quality of life.
Exclusion criteria
- significant neurological disorder
- significant dementia or neurocognitive limitations as assessed by neuropsychiatry (when necessary)
- severe psychiatric illness with suicidal ideations
- previous surgery to destroy the target region of the brain
- surgical contraindications to DBS
- current major medical problems that affect brain anatomy,neurochemistry, or function, e.g., liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, hypothyroidism, auto-immune diseases, and any current of history of brain disorder (seizure disorder, stroke, dementia, meningitis, encephalitis, degenerative neurologic diseases and head injury with loss of consciousness for any period of time)
- family history of hereditary neurologic disorder, besides essential tremors ET
- floating metallic objects in the body
- alcohol or substance abuse/dependence in the past 6 months.
Where
- Manhasset, New York
Collaborators
National Institutes of Health (NIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 8, 2025 · Source of record for eligibility and locations